Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Camurati-Engelmann Disease

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Antibodies

Immunomodulating Agents

Antibodies, Bispecific

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunologic Factors

Treatment is AGEN1423 plus balstilimab for 4 cycles (8 weeks) followed by balstilimab alone for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Balstilimab will be administered every 2 weeks.

Treatment is AGEN1423 plus balstilimab in combination with gemcitabine and nab-paclitaxel for 2 cycles (8 weeks) followed by balstilimab in combination with gemcitabine and nab-paclitaxel for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Balstilimab will be administered once every 2 weeks.

via IV, dosage per protocol, once every 2 weeks for up to 8 weeks

AGEN1423

via IV, dosage per protocol, once evert 2 weeks, up to 2 years

Balstilimab

Nab-paclitaxel

Bruno Bockorny, MD

The goal of this research study is to asses the safety and efficacy of the combination of AGEN1423 and Balstilimab with or without chemotherapies, gemcitabine and nab-paclitaxel, for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) which has progressed after at least one previous line of cancer therapy.

The names of the study drugs involved in this study are:

* AGEN1423
* Balstilimab

Participants will receive study treatment for about 2 years and will be followed for 1 year after.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Participants will receive study treatment for about 2 years and will be followed for 1 year. If the combination is considered to be safe and tolerable, and objective response is achieved in at least 2 patients, the study will proceed to Cohort 2.
* This research study involves immunotherapy. The names of the study drugs involved in this study are:
* AGEN1423
* Balstilimab

It is expected that about 24 people will take part in this part of this research

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved AGEN1423 as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved Balstilimab as a treatment for any disease.

Agenus, a pharmaceutical company, is supporting this research study by providing funding and study drug for the research study.

AGEN1423 Plus Balstilimab With or Without Chemo in Pancreatic Cancer

A Phase 2 Study of AGEN1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, in Combination With Balstilimab, With or Without Chemotherapy in Subjects With Advanced Pancreatic Cancer.

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria, using the modified intent-to-treat (mITT) analysis set

Disease control rate (DCR) defined as the sum of stable disease, partial and complete responses according to RECISTv1.1 criteria.

Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per RECISTv1.1, until the first date that recurrent or progressive disease is objectively documented. Patients without progressive disease are censored at the date of last disease assessment.

Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.

Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment.

All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AGEN1423 Plus Balstilimab With or Without Chemo in Pancreatic Cancer	NCT05632328	Advanced Pancre... Pancreatic Duct... Pancreatic Canc...	AGEN1423 Balstilimab Gemcitabine Nab-paclitaxel	18 Years -	Beth Israel Deaconess Medical Center
AGEN1423 Plus Balstilimab With or Without Chemo in Pancreatic Cancer	NCT05632328	Advanced Pancre... Pancreatic Duct... Pancreatic Canc...	AGEN1423 Balstilimab Gemcitabine Nab-paclitaxel	18 Years -	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for agen1423

Every month we try and update this database with for agen1423 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for agen1423

Every month we try and update this database with for agen1423 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for agen1423 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.